MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH INTELLIVUE; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number M8004A

Device Problems Defective Alarm (1014); Failure to Analyze Signal (1539)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762); Cardiopulmonary Arrest (1765); Death (1802)

Event Date 12/26/2019

Event Type  Death  

Event Description

A female patient was on the philips intellivue mp50 cardiac monitor and here for chest pain greater than 8 hours and after cocaine use.A 2 star alarm for st elevation was found.Upon further review after the event, patient was found to have gone into ventricular fibrillation approximately 2 minutes later and continued.There was no alarm at this time.Review of the monitor alarms shows that the monitor had a red alarm for asystole, despite the fact that patient was in ventricular fibrillation (approximately 3 minutes later).This alarm was after the patient had been in ventricular fibrillation for 3 minutes after review of the rhythm strip.Upon discovery of the patient being in ventricular fibrillation, cpr with acls protocol was started.After defibrillation and epinephrine administration, the patient had return of spontaneous circulation.She was intubated and admitted to the icu where she underwent cardiac arrest multiple times and died within 5.5 hours of arrival to the emergency department.Manufacturer response for cardiac monitor, intellivue mp50 (per site reporter).Under investigation at this time.

• Brand Name: INTELLIVUE
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH; 3000 minuteman road mail stop 4202; andover MA 01810
• MDR Report Key: 9646790
• MDR Text Key: 176985999
• Report Number: 9646790
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M8004A
• Device Catalogue Number: 20164733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 14235 DA